A New Double-Cone Nitinol Device for PDA Occlusion: Design, Manufacturing and Initial In Vivo Results

Abstract

Use of occluder devices for a patent ductus arteriosus (PDA) closure is restricted to small diameter PDAs and involves high device costs. The objective of this study was to develop a new nitinol implant for the closure of a PDA and to evaluate its safety and efficacy in an animal model. The design consists of a device that promotes thrombus formation in the PDA. The device has a double-cone shape with their vertices joined. The cones are made of a nitinol wire helix with dacron fibers attached. The proximal end of the helix can be screwed to a conventional catheter release wire. In vitro testing was performed to verify the effectiveness of the implantation of the device and its releasing system; all trials (n = 30) were successful, showing accurate placement and release of the device. Complete and successful implantation of the device was achieved in all in vivo experiments (n = 5). There was one case of embolization due to premature detachment; a second device was successfully implanted. Histological evaluation after 42.3 +/- 3.1 days demonstrated complete PDA occlusion. The retrieved PDA showed total closure of the defect, endothelization of the PDA outlets and proper lodging of the device.

Multicenter nit‐occlud® PDA‐R patent. Ductus arteriosus occlusion device trial: Initial and six‐month results

“…In contrast to the Amplatzer Duct Occluder I (ADO I, AGA Medical, Golden Valley, MN), proper release of the device requires only a small amount of force (5N) without significant longitudinal traction and allows for an accurate visualization of the device position prior to final release. The ADO I, on the other hand, is released by unscrewing the delivery cable, which can lead to premature release .…”

A Novel Nitinol Spherical Occlusion Device for Liver Cancer

“…For example, Vallecilla et al developed a double-cone shaped nitinol device made with nitinol mesh wires and dacron fibers for PDA occlusion [12]. Transcatheter closure for PDA is an established technique today, making itself a potential treatment option for PDA.…”